Kornimate/medical-research-clean huggingface dataset:
a phase 1 study of pegilodecakin (ly3500518) in participants with advanced solid tumors

Conditions: Melanoma; Prostate Cancer; Ovarian Cancer; Renal Cell Carcinoma; Colorectal Carcinoma; Pancreatic Carcinoma; Non-small Cell Lung Carcinoma; Solid Tumors; Breast Cancer

Summary: this is a first-in-human, open-label, dose escalation study to evaluate the safety and tolerability of pegilodecakin in participants with advanced solid tumors, dosed daily subcutaneously as a monotherapy or in combination with chemotherapy or immunotherapy.


Eligibility criteria:
inclusion criteria: part a escalation cohorts: o histologically or cytologically confirmed advanced malignant solid tumor, limited to melanoma, castrate resistant prostate cancer (crpc), ovarian cancer (ovca), renal cell carcinoma, colorectal carcinoma (crc), pancreatic carcinoma or non-small cell lung carcinoma (nsclc) that is refractory to, intolerant of, for which no standard of therapy is available or where the participant refuses existing therapies part a expansion cohorts, part b and c escalation and expansion cohorts: * tumors with all histological diagnosis or tissue origin may be enrolled * participants must have failed prior standard curative chemotherapy for their disease, refuse existing therapies or the proposed chemotherapy regimen to which pegilodecakin is added represents an acceptable standard treatment for their disease. * measurable or evaluable disease according to irrc or bone metastatic disease evaluable by prostate cancer working group 2 criteria (pcwg2) for castration-resistant prostate cancer (crpc) * at least 18 years of age * performance status of 0 or 1 * adequate organ function exclusion criteria: * hematologic malignancies * pregnant or lactating * present or history of neurological disorders such as multiple sclerosis and guillain barre or inflammatory central nervous system/peripheral nervous system (cns/pns) disorders * myocardial infarction within the last 6 months * unstable angina, or unstable cardiac arrhythmia requiring medication * surgery within the last 28 days * systemic fungal, bacterial, viral, or other infection * history of bleeding diathesis within the last 6 months * positive for human immunodeficiency virus (hiv), hepatitis c, or hepatitis b

Keywords: phase 1/phase 1b oncology cancer solid tumors
biomechanical properties of keratoconic eyes

Conditions: Keratoconus

Summary: in keratoconus (kc) corneal thinning and protrusion can cause myopia and irregular astigmatism, affecting vision. the biomechanical properties of the cornea is maintained by an intricate collagen network, which is responsible for its shape and function. in kc this collagen network is disrupted resulting in the cornea losing its shape and function. keratoconic changes are focal and localised to certain regions of the cornea and the early detection of these changes is challenging. screening methods include corneal topography (evaluation of anterior corneal surface curvature), tomography (assessing the morphological features of the anterior segment) and aberrometry (measuring the optical aberrations of the eye). more recent research suggests that the biomechanical destabilization of the cornea may precede topographic and tomographic evidence of kc. management of kc depends on disease severity with severe cases being treated with keratoplasty and less severe cases with cornealcollagencrosslinking (cxl). cxl is an emerging technique, which aims to increase the biomechanical strength of the keratoconic cornea. despite strong evidence of changes in the biomechanical properties in human corneas following cxl, there is a significant need for accurate measures of biomechanical changes in vivo pre and post cxl. until recently technical limitations have restricted the ability to assess the biomechanical properties of the whole cornea in vivo. with the introduction of the corvisst (oculus) it is now possible to assess regional biomechanical behaviour of the cornea. the output from the device provides a variety of parameters to indicate the cornea's biomechanical strength. to date, the association between the deflection behaviours in various regions of the cornea in keratoconic eyes preand post cxl has not been studied. in order to effectively assess the clinical benefits of cxl such information is vital. the primary goal of this investigation is to investigate regional biomechanical properties of the keratoconic eye before and after cxl.


Eligibility criteria:
inclusion criteria: * adult subjects over the age of 18 with keratoconus who are enrolled for collagen crosslinking treatment exclusion criteria: * any patient who has had surgical complications will also be excluded from participation in the study. determination during enrolment: * pregnancy or breastfeeding during the study * any kind of systemic disease which affect collagen and the body water regulation system (marfan syndrome, osteogenesis imperfect, pseudozanthoma elasticum, ehlersdanlos, diabetes, rosacea, acne, cardiovascular disease, thyroid disease)
prospective longitudinal effects of intra-articular corticosteroid injection on synovial fluid oxygen

Conditions: Rheumatoid Arthritis; Psoriatic Arthritis

Summary: inflammatory arthritis such as rheumatoid arthritis (ra) and psoriatic arthritis (psa) are characterized by synovial inflammation of joints, potentially leading to joint destruction and functional disability. inflamed joints have lower oxygen levels. studying how oxygen level within the joint affect inflammation may lead to new treatments for patients with arthritis. anti-inflammatory corticosteroid injection into the joint is well tolerated and widely used in clinical practice but its effects on oxygen level within joints is unknown. therefore, patients who require corticosteroid injection into the joint as routine clinical care will have biological samples collected before and after the injection. this will give new information to put into context the biological effects within the joint, and accelerate development of new treatment approaches in the future.


Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * male or female, aged 18 years or above. * fulfil american college of rheumatology/european league against rheumatism criteria (acr/eular) 2010 rheumatoid arthritis classification criteria or fulfil classification criteria for psoriatic arthritis 2006 (caspar). * participant has been selected for intra-articular corticosteroid injection as part of their routine clinical care. * selected joint for biopsy must be minimum grade 2 synovial thickening for large joint (knee) and medium joint (wrist), or minimum grade 3 synovial thickening for small joint (metacarpophalangeal). exclusion criteria: * current enrolment in any other clinical study involving an investigational study treatment. * intramuscular, intravenous or intra-articular administration of corticosteroid within 4 weeks prior to baseline visit. * oral corticosteroid \> 10 mg/day prednisolone or equivalent within 4 weeks prior to baseline visit. * oral corticosteroid dose not stable for at least 4 weeks prior to baseline visit. * oral non-steroidal anti-inflammatory drugs (including aspirin \> 75 mg/ day and selective-cyclooxygenase inhibitors) dose not stable for at least 4 weeks prior to baseline visit. * disease modifying anti-rheumatic drugs (dmards) dose not stable for at least 4 weeks prior to baseline visit. * history of septic arthritis. * participants on warfarin, heparin, low molecular weight heparin, direct oral anticoagulants. oral anti-platelet agents are permitted. * history of haemophilia.
improving decision making about feeding options for dementia

Conditions: Dementia

Summary: this study is a randomized trial to test whether a decision aid can help to improve the quality of decision making about feeding options in care of patients with dementia.

this research study is a cluster randomized controlled trial of a decision aid to improve decision-making about feeding options for patients with advanced dementia. surrogate decision-makers in the nursing homes randomized to the intervention will review the decision aid and be prompted to discuss it with the primary health care provider, while those in the control sites receive usual care. we measure the immediate, 1 and 3 month effects of the decision aid on the quality of surrogate decision-making for nursing home residents with advanced dementia.

Eligibility criteria:
inclusion criteria: * dementia diagnosis * advanced cognitive impairment * feeding problem * age \>= 65 * surrogate decision maker exclusion criteria: * feeding tube decision made * hospice * bmi \> 26 * major psychosis or developmental delay

Keywords: dementia nutrition feeding
vinorelbine and paclitaxel plus radiation therapy in treating patients with advanced cancer arising in the pelvis

Conditions: Bladder Cancer; Cervical Cancer; Endometrial Cancer; Vaginal Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining radiation therapy with chemotherapy with may kill more tumor cells. purpose: phase i trial to study the effectiveness of chemotherapy with vinorelbine and paclitaxel plus radiation therapy in treating patients with advanced cancer arising in the pelvis.

objectives: i. assess the toxic effects of vinorelbine given on a weekly schedule combined with standard whole pelvic radiation therapy. ii. determine the maximum tolerated dose (mtd) of vinorelbine given on a weekly schedule combined with standard whole pelvic radiation therapy. iii. access the toxic effects of paclitaxel given weekly in combination with the regimen determined to be the mtd of vinorelbine. iv. determine the mtd of paclitaxel given weekly in combination with the regimen determined to be the mtd of vinorelbine. outline: part i: vinorelbine iv bolus is administered over 8-10 minutes on day 1 prior to radiation therapy. whole pelvic radiation treatment is given on days 1-5 followed by 2 days of rest. the treatment volume encompasses all suspected pelvic disease with a minimum of 1 cm margin. cycles repeat weekly. dose of vinorelbine is escalated in cohorts of at least 3 patients until maximum tolerated dose (mtd) is determined. part ii: paclitaxel is infused over 1 hour immediately following vinorelbine at the mtd, as determined in part i. dose of paclitaxel is escalated in cohorts of at least 3 patients until the mtd is determined. at least 6 patients are treated at the mtd for both parts i and ii of the study. patients are followed for late and chronic toxicities. projected accrual: projected accrual is 12 patients per year for approximately 3 years.

Eligibility criteria:
disease characteristics: histologically confirmed locally advanced carcinoma of the uterine cervix, vagina, or bladder or other pelvic malignancy for which whole pelvic radiation therapy is planned metastatic disease is permitted patient characteristics: age: over 18 performance status: calgb 0-2 hematopoietic: wbc at least 3,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin within normal limits renal: creatinine no greater than 2.5 mg/dl cardiovascular: no unstable angina or myocardial infarction in previous 6 months other: not pregnant no significant concomitant illness, uncontrolled infection, or cirrhosis prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy endocrine therapy: not specified radiotherapy: no prior whole pelvic radiation therapy surgery: not specified

Keywords: stage ii cervical cancer stage iii cervical cancer stage iv cervical cancer stage ii vaginal cancer stage iii vaginal cancer stage iva vaginal cancer stage ivb vaginal cancer stage ii endometrial carcinoma stage iii endometrial carcinoma stage iv endometrial carcinoma stage ii bladder cancer stage iii bladder cancer stage iv bladder cancer
a feasibility study for growth bone vertically with titanium mesh and allograft in lower posterior jaw

Conditions: Alveolar Bone Loss

Summary: this study will involve placing donor bone into the back of lower jaw then covering with a newly designed titanium mesh. the mesh will then stay in the mouth for 4 months before it will be removed. implants will be placed in the newly formed bone. the goal of this study is to test how well using a newly designed titanium mesh and bone particles can grow bone in the back of the lower jaw. the investigators are also checking if the newly formed bone will stay around implants that will have been in use for 12 months.

inclusion criteria * patients are at least 18 years old * at least two adjacent back teeth in the lower jaw are missing * no medical contraindication to dental surgery * inadequate vertical ridge height at edentulous region (less than 10mm) exclusion criteria * unstable systemic diseases or conditions that would compromise the healing potential * patients with osseous metabolic disorders (e.g., osteoporosis, paget's disease etc.) * patients who are pregnant or expect to get pregnant * patients with unstable dental disease (e.g. caries and periodontitis) in the surgical sextant

Eligibility criteria:
inclusion criteria: * systemically healthy patients (asa i or ii) * non-smoker or light smokers (\< 10 cigarettes per day) * good oral health (fmps and fmbs \<20%) * at least two adjacent mandibular posterior teeth are missing * inadequate vertical ridge height at edentulous region (less than 10mm) * missing teeth for ≥ 3 months exclusion criteria: * unstable and complicated systemic diseases or chronic disorders precluding surgical procedures * systemic diseases with compromised healing potentials (uncontrolled diabetes mellitus, hiv infections, etc.) * bone disorders (hyperparathyroidism, osteoporosis, paget's disease) * pregnant or expecting to become pregnant * currently smoking (≥ 10 cigarettes/day) * poor oral hygiene (≥20% modified o'leary plaque index) * severe grinding, clenching, tmj disorder * untreated dental disease (periodontitis, caries, abscesses) in the research quadrant * teeth exhibiting periapical pathology or purulence (symptomatic) in the research quadrant
use quantitative microradiography to predict the periprosthetic bone loss in distal femur after total knee arthroplasty

Conditions: Periprosthetic Bone Loss in Total Knee Replacement

Summary: the investigators hypothesized that the microarchitecture of bone influence the degree of periprosthetic bone loss after total knee arthroplasty surgery. the investigators collected the bone fragment at the distal femur while performing total knee replacement and take quantitative radiography analysis . before and after the surgery(6 month ,12 month) , the investigators check the bmd at identical location of the distal femur by using dual energy absorptiometry. the investigators will use linear regression to evaluate the relationship between the microarchitecture and the degree of bone loss.


Eligibility criteria:
inclusion criteria: * severe knee osteoarthritis * post menopausal women exclusion criteria: * immune disease * end stage of renal disease who receive dialysis * history of fracture at ipsilateral distal femur

Keywords: osteoarthritis periprosthetic bone loss dual energy x-ray absorptiometry
the outcomes of nricm101 on sars-cov-2 (covid-19) infection

Conditions: SARS-CoV-2; Covid 19

Summary: traditional chinese medicine is regarded as a dietary supplement in many countries around the world. dietary supplement, nricm101, has been available for people who diagnosed, suspected or prevented for coronavirus disease 2019 (covid-19) in september 2020. it is expected to help people not to progress to severe illness, and reduce lung damage and mortality. the investigators gather the effects of people who taking nricm101 using the real-world big data study and the network feedback information collection model. this study can be used as a reference for global prevention and control of coronavirus disease 2019 (covid-19).

the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) is raging around the world. because of its strong spread, variability, survivability, and invisibility, the number of infected people rise rapidly. on march 11, 2020, the who officially declared covid-19 as a pandemic disease. as of october 3, 2020, the number of confirmed cases has exceeded 34 million, and the cumulative deaths have exceeded 1 million. there are still no drugs to treatment the coronavirus disease 2019 (covid-19). due to the mutation of virus rapidly, vaccine development cannot be completed in a short period of time. at the beginning of the infection outbreak, the governments of china and south korea, adopted a cooperative of chinese and western medicine to treatment the coronavirus disease 2019 (covid-19). in addition to the reported good clinical effects, chinese medicine prescriptions have included in diagnosis and treatment guideline of these two countries. traditional chinese medicine is regarded as a dietary supplement in many countries around the world. dietary supplement, nricm101, has been available for people who diagnosed, suspected or prevented for coronavirus disease 2019 (covid-19) in september 2020. it is expected to help people not to progress to severe illness, and reduce lung damage and mortality. the investigators gather the effects of people who taking nricm101 using the real-world big data study and the network feedback information collection model. this study can be used as a reference for global prevention and control of coronavirus disease 2019 (covid-19).

Eligibility criteria:
inclusion criteria: * subjects who confirmed, suspected or prevented infected of covid 19 disease and take dietary supplement nricm101 exclusion criteria: * those who refuse to participate in observational research.

Keywords: nricm101 covid 19 sars-cov-2
value of flt pet/ct in radium-223 therapy of mcrpc patients

Conditions: Metastatic Prostate Carcinoma

Summary: the aim of the study is to investigate whether positron emission tomography (pet) using the tracer 18f-fluorothymidine (flt) can provide information on proliferative activity in bone marrow of patients receiving radium 223 therapy and potentially be a predictive marker of hematological toxicity


Eligibility criteria:
inclusion criteria: * metastatic castration resistant prostate cancer * eligible for radium-223 therapy * informed consent exclusion criteria: * inability to understand study protocol * extensive metastatic involvement of the axial skeleton ("superscan" on bone scintigraphy)

Keywords: radium-223 therapy
anidulafungin vs amphotericin b safety in high risk hepatic transplant recipients

Conditions: Liver Disease; Fungal Infection

Summary: the study is a randomized, open-label safety study comparing the use of anidulafungin (200 mg i.v. as initial dose and 100 mg/d i.v. in subsequent doses) vs liposomal amphotericin b (3 mg/kg/d i.v.) in hepatic transplant recipients who have high risk of fungal infection.


Eligibility criteria:
inclusion criteria: * at least 18 years old * signature of icf * negative pregnancy test (women of child bearing potential) * patients who comply with at least one of the following (a or b): a: one of the following criteria (major criteria): * re-transplant due to severe dysfunction of a previous hepatic graft * requirement of any renal substitutive therapy, including dialysis or hemofiltration * fulminant hepatitis requiring hepatic transplant b: two of the following criteria (minor criteria): * post-transplant renal impairment (defined as crcl\< 50 ml/min) 30 days after transplantation * intra surgery blood transfusion of at least 40 units * choledochal jejunectomy * 2 or more candida sp cultures (nasal, pharynx, rectal) from 48 hours pre- to 48 hours post-hepatic transplant * post transplant re-intervention (laparotomy) exclusion criteria: * hypersensibility to amphotericin b or candin * patients who have received any other antifungal (excluding fluconazole or oral nystatin for a maximum of 7 days) * documented or suspected fungal infection * pregnant women of women who do not accept to us a valid anticonceptive method * any other disease or medical condition that makes the patient not adequate to participate in the trial

Keywords: liver transplantation hepatic transplant antifungal prophylaxis anidulafungin liposomal amphotericin b
improving primary care access to urinary incontinence treatment for women veterans

Conditions: Urinary Incontinence

Summary: the pursuit project aims to improve access to evidence-based nonsurgical ui treatment for women veterans in the southeast region of the united states using the most effective remote delivery modality. using cluster randomization, the study will compare two models at the practice level: (1) the use of a practice facilitation toolkit with a mhealth ui modality alone and (2) the practice facilitation toolkit with a mhealth ui model combined with education on clinical pathways for consultation. patient level outcomes related to ui symptom improvement will be compared. patient and provider perceptions of factors that could influence future remote ui treatment scalability will also be assessed. all primary care practices will receive practice facilitation with a pursuit toolkit that includes (1) 1-2 visits with a practice facilitator; (2) mobile-health or mhealth application training (mat); 3) online resource hub; and (4) health information technology (hit) assistance. pursuit's future goal is to disseminate the most effective modality for delivering nonsurgical ui treatment for women veterans nationally within the vha.

pursuit aims to recruit 62 practices to participate in the trial implementation at 50 practices. specifically, community-based outpatient clinics (cbocs) from va integrated service network (visn) 7 will be targeted, spanning the states of alabama, georgia, and south carolina. the project will focus on visn 7 cbocs, serving at least 50 women veterans with primary care services, will be recruited through connections with local women's health providers. the team estimates outreach to approximately 50,000 women veterans and estimates that 30 percent (n=15,000) of these women will have ui symptoms, and, among those, 15 percent (n=2,500) will participate.

Eligibility criteria:
inclusion criteria: * veteran * english-speaking, community-dwelling women veterans * diagnosis of ui (all types) * access to the internet via a mobile device or computer exclusion criteria: * women veterans who are currently pregnant or less than 12 weeks postpartum

Keywords: women veterans behavioral treatment primary care
an observational study of peginterferon alfa-2a in combination with ribavirin in participants with chronic hepatitis c and compensated liver cirrhosis

Conditions: Hepatitis C, Chronic

Summary: this prospective observational study will evaluate the efficacy and safety of peginterferon alfa-2a in combination with ribavirin in participants with chronic hepatitis c, including participants with compensated liver cirrhosis, in clinical practice.


Eligibility criteria:
inclusion criteria: * serologically confirmed chronic hepatitis c (chc), hepatitis c virus (hcv) rna detectable * compensated liver cirrhosis (child-pugh class a) included * initiating combined therapy with peginterferon alfa-2a and ribavirin exclusion criteria: * human immunodeficiency virus (hiv) co-infection * contraindications for combined therapy according to actual prescribing information